The "ComPAS Trial" combined treatment model for acute malnutrition: study protocol for the economic evaluation

Natasha Lelijveld, Jeanette Bailey, Amy Mayberry, Lani Trenouth, Dieynaba S N'Diaye, Hassan Haghparast-Bidgoli, Chloe Puett, Natasha Lelijveld, Jeanette Bailey, Amy Mayberry, Lani Trenouth, Dieynaba S N'Diaye, Hassan Haghparast-Bidgoli, Chloe Puett

Abstract

Background: Acute malnutrition is currently divided into severe (SAM) and moderate (MAM) based on level of wasting. SAM and MAM currently have separate treatment protocols and products, managed by separate international agencies. For SAM, the dose of treatment is allocated by the child's weight. A combined and simplified protocol for SAM and MAM, with a standardised dose of ready-to-use therapeutic food (RUTF), is being trialled for non-inferior recovery rates and may be more cost-effective than the current standard protocols for treating SAM and MAM.

Method: This is the protocol for the economic evaluation of the ComPAS trial, a cluster-randomised controlled, non-inferiority trial that compares a novel combined protocol for treating uncomplicated acute malnutrition compared to the current standard protocol in South Sudan and Kenya. We will calculate the total economic costs of both protocols from a societal perspective, using accounting data, interviews and survey questionnaires. The incremental cost of implementing the combined protocol will be estimated, and all costs and outcomes will be presented as a cost-consequence analysis. Incremental cost-effectiveness ratio will be calculated for primary and secondary outcome, if statistically significant.

Discussion: We hypothesise that implementing the combined protocol will be cost-effective due to streamlined logistics at clinic level, reduced length of treatment, especially for MAM, and reduced dosages of RUTF. The findings of this economic evaluation will be important for policymakers, especially given the hypothesised non-inferiority of the main health outcomes. The publication of this protocol aims to improve rigour of conduct and transparency of data collection and analysis. It is also intended to promote inclusion of economic evaluation in other nutrition intervention studies, especially for MAM, and improve comparability with other studies.

Trial registration: ISRCTN 30393230 , date: 16/03/2017.

Keywords: Community management of acute malnutrition; Cost-consequence analysis; Cost-effectiveness; Moderate acute malnutrition; Severe acute malnutrition.

Conflict of interest statement

Ethics approval and consent to participate

The ComPAS study, including the economic evaluation, was approved by the Kenya Medical Research Institute (KEMRI) (5/1/2017, ref: 551), the Ministry of Health Internal Review Board, South Sudan (21/11/2016), and the London School of Hygiene and Tropical Medicine (28/11/2016, ref: 11826). This protocol, specific to the economic analysis, was reviewed by the International Rescue Committee Institutional Review Board (Ref H1.00.017). Informed written consent is obtained prior to all surveys and interviews (see model consent form in Additional file 2).

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Depiction of hypothesised economic outcome of the ‘combined protocol’ on the cost-effectiveness matrix. We hypothesise that the ‘combined protocol’ for treatment of severe and moderate acute malnutrition will have as high recovery rates as the standard treatment protocol, but at a lower cost
Fig. 2
Fig. 2
Schedule of enrolment, interventions and assessments

References

    1. UN General Assembly. Sustainable Development Goals. 2015. . Accessed 24 Jul 2017.
    1. Black RE, et al. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008;371(9608):243–260. doi: 10.1016/S0140-6736(07)61690-0.
    1. Lelijveld N, et al. Chronic disease outcomes after severe acute malnutrition in Malawian children (ChroSAM): a cohort study. Lancet Glob Health. 2016;4(9):e654–e662. doi: 10.1016/S2214-109X(16)30133-4.
    1. UNICEF, WHO, The World Bank Group. Joint Child Malnutrition Estimates - Levels and Trends. 2016. . Accessed 6 Jan 2018.
    1. Collins S, et al. Management of severe acute malnutrition in children. Lancet. 2006;368(9551):1992–2000. doi: 10.1016/S0140-6736(06)69443-9.
    1. Lenters LM, et al. Treatment of severe and moderate acute malnutrition in low-and middle-income settings: a systematic review, meta-analysis and Delphi process. BMC Public Health. 2013;13(3):S23. doi: 10.1186/1471-2458-13-S3-S23.
    1. Bailey J, et al. Combined protocol for SAM/MAM treatment: The ComPAS study. Field Exchange. 2016;53:44.
    1. Bailey J, et al. Combined Protocol for Acute Malnutrition Study (ComPAS): Design of a multi-site cluster randomized, non-inferiority trial in Rural South Sudan and Urban Kenya. BMC Trials, 2018.
    1. Puett C, et al. Cost-effectiveness of the community-based management of severe acute malnutrition by community health workers in southern Bangladesh. Health Policy Plan. 2013;28(4):386–399. doi: 10.1093/heapol/czs070.
    1. Wilford R, Golden K, Walker DG. Cost-effectiveness of community-based management of acute malnutrition in Malawi. Health Policy Plan. 2011;27(2):127–137. doi: 10.1093/heapol/czr017.
    1. Bachmann MO. Cost effectiveness of community-based therapeutic care for children with severe acute malnutrition in Zambia: decision tree model. Cost Effect Resour Alloc. 2009;7(1):2. doi: 10.1186/1478-7547-7-2.
    1. Tekeste A. Cost-effectiveness analysis of community-based and inpatient therapeutic feeding programs to treat severe acute malnutrition in Sidama Zone, SNNPRS, Ethiopia. Ethiopia: MPh thesis, Jimma University; 2007.
    1. International Rescue Committee . Cost-Efficiency Analysis. Treating Severe Acute Malnutrition. New York: Best Use of Resources Initiative, IRC; 2016.
    1. Maust A, et al. Severe and moderate acute malnutrition can be successfully managed with an integrated protocol in Sierra Leone. J Nutr. 2015;145(11):2604–2609. doi: 10.3945/jn.115.214957.
    1. Skordis-Worrall J, et al. Protocol for the economic evaluation of a community-based intervention to improve growth among children under two in rural India (CARING trial) BMJ Open. 2016;6(11):e012046. doi: 10.1136/bmjopen-2016-012046.
    1. Olack B, et al. Nutritional status of under-five children living in an informal urban settlement in Nairobi. Kenya. J Health Popul Nutr. 2011;29(4):357.
    1. Kenya National Bureau of Statistics. Kenya Demographic and Health Survey. 2014. . Accessed 6 Jan 2018.
    1. The World Bank. South Sudan - Fifth Population and Housing Census 2008. 2008. . Accessed 6 Jan 2018.
    1. International Rescue Committee. Integrated nutritional anthropometry and mortality surveys, Aweil south county northern Bahr El Ghazal state republic of south Sudan. IRC New York. .
    1. The World Bank. The World Bank in South Sudan: Overview. 2009. . Accessed 24 Jul 2017.
    1. Bailey J, Kerac M, Opondo C. Combined protocol for acute malnutrition study (ComPAS) ISRCTN30393230: ISRCTN; 2016.
    1. Nwayo M, Myatt M. Causal analysis and the SQUEAC toolbox. Field Exchange. 2012;42:37–38.
    1. FANTA-2 . User’s Guide to the CMAM Costing Tool: A Tool for Costing Community-Based Management of Acute Malnutrition at the National, Subnational, and District Levels. Washington, DC: FANTA-2, AED; 2011.
    1. World Health Organization . Choosing Interventions that are Cost Effective (WHO-CHOICE) Geneva: WHO; 2010.
    1. Husereau D, et al. Consolidated health economic evaluation reporting standards (CHEERS) statement. Cost Effect Resour Alloc. 2013;11(1):6. doi: 10.1186/1478-7547-11-6.

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